Oxford vaccine
Vexed over vaccines
The Directorate General of Health Services announced this week that Bangladesh’s stock of Covid-19 vaccines was running out, with only some 1.4 million jabs remaining in government hands. Given the current crisis in India, there is little to no hope of receiving the next consignment in accordance with the contract signed between Beximco Pharmaceuticals and the Serum Institute of India anytime soon.
Speaking at a virtual press briefing, DGHS spokesperson Robed Amin said, “We had around 10.02 million vaccine doses in our hands…around 8.8 have already been administered as the first and second doses. Now we have some 1.4 million doses in stock.”
He went on to warn that there would be a vaccine crisis if a fresh consignment does not arrive in the country before the existing stock is exhausted. Robed said around 5.8 million people have so far received the first dose of the vaccine while 3 million of them have got the second, booster dose to complete their course of the Oxford University-AstraZeneca vaccine. That leaves 2.8 million people yet to complete the course, of which 1.4 million can be covered from the current stock, since the government has stopped registering any new recipients through the Shurokkha app.
Clearly, the priority has shifted to covering these people rather than reaching a situation where a large number of them are left in limbo, considering the uncertainty over when Serum may resume supplies. As reported before, the government is now looking at alternative suppliers, something they would possibly have been well-advised to do earlier, from Russia and China, as well as others. But in the absence of any clear data yet on whether the vaccines can be mixed or matched, concentrating the remaining doses on letting as many people as possible complete their course is only the right thing to do.
Till Eid, which is about when supplies are estimated to lost, you’re unlikely to see any new faces popping up on your social media feed with their ‘vaccine selfie’. Unless they skipped it the first time, which is unlikely.
From pillar to post
Reaffirming that the government is making all-out efforts to collect Covid-19 vaccines from different sources, Health Minister Zahid Maleque on Thursday (May 6) said they are now “at the stage” of signing a deal with Russia to procure the Sputnik V vaccine.
Speaking at a virtual discussion arranged by Bangladesh Private Medical College Association, he said they are also trying to procure the Oxford–AstraZeneca vaccine from other countries besides India – AstraZeneca has licensed production in some 15 countries already.
Also read: Russian Vaccine Sputnik V: Things we should know to fight COVID-19
“We’ve been using the AstraZeneca vaccine as we had placed an order for 3 crore (30 million) doses of it. We’ve got only 70 lakh (7 million) jabs in addition to 30 lakh (3 million) that came as a gift…but now we don’t have that much vaccine in our stock and whatever is left will be given as the second dose,” the minister said.
He said the prime minister, Health Ministry, Foreign Ministry and other relevant ministries are making joint efforts to procure vaccines from other sources.
“We’ve already made a huge progress in discussions with Russia over procuring its vaccine … now we’re at the stage of signing a deal in this regard,” Maleque said.
He said they are also in talks with China to have Sinopharm’s Covid vaccine. “They informed us that five lakh (500,000) doses will arrive in Bangladesh by May 12. We’ve also sent a letter to them seeking more vaccine doses.”
The minister said the Chinese government is now assessing the possibility of vaccine export to Bangladesh. It must be observed that it sounds like an uncharacteristically conservative offer from Beijing, for which the episode back in August 2020 comes to mind, when it all seemed very close to an agreement with the Chinese for vaccine supply, before the government seemed to get cold feet.
Getting back to Maleque, he was desperate to explain the government’s all-out efforts to get the vaccine. “Even, we’re trying to have AstraZeneca’s vaccine from other countries as it’s being manufactured in different countries. So, every effort is there to bring vaccines. We hope our efforts will yield good results, and we may be able to give you good news over the vaccine very soon,” he said.
The minister also said they will encourage the private sector if it tries to manufacture vaccines in Bangladesh. “If anyone can produce vaccines, we’ll provide all-out support, and it’s my commitment.”
Speaking at the same programme, State Minister for Disaster Management and Relief Dr Enamur Rahman said there is no alternative to vaccinating people to control the coronavirus. He too tried to assure everyone the government is working sincerely on procuring vaccines from Russia, China and other sources as there has been a crisis of AstraZeneca’s jabs in India.
Also read: What does it feel like to get COVID-19 after taking the vaccine?
He gave some hint as to what the government is looking at as a way to get past the pandemic, saying that all the pandemics that emerged in the world earlier had been brought under control through vaccination, although that’s not entirely true. “We hope we’ll be able to control the corona pandemic by vaccinating 60-80 percent of our people.”
What sort of timeframe they’re looking at to achieve that is up in the air, but it could be a good 2 years. Cases have been coming down in Bangladesh recently, but you never know when there can be another wave. The lesson we must heed going forward, is that never to close out any options during this crisis. And not to rest on our haunches. In that, the public has a role too, most evidently in maintaining the public health guidelines we’re now getting used to.
A shot at salvation?
It is of course well-documented by now that the pandemic has exposed some dangerous inequities between the rich world and the rest. The kind of problem the Bangladeshi authorities are dealing with today is scarcely seen in the West. While one in four citizens of rich nations have had a vaccine, just one in 500 people in poorer countries have done so, meaning the death toll continues to climb as the virus remains out of control. According to Oxfam, an international NGO, epidemiologists are predicting we have less than a year before mutations could render the current vaccines ineffective.
One of the reasons Pharma companies have been able to generate such large profits is because of intellectual property Last week, 175 former heads of state and Nobel Prize winners, including Gordon Brown, Ellen Johnson Sirleaf and Francoise Hollande wrote to President Biden to support the temporary waiving of intellectual property rights that restrict production to a handful of companies (those that develop the vaccine and others who obtain the license from them), to enable the rapid scale up of vaccine production across the world. They join the 1.5 million people in the US and other nations who have signalled their support for a People’s Vaccine.
Over 100 low- and middle-income nations, led by India and South Africa, are calling at the World Trade Organisation for a waiver of intellectual property protections on COVID-19 products during the pandemic, a move that had so far been opposed by the US, EU and other rich nations.
In a major shift, the Biden administration in the US this week joined the calls for more sharing of the technology behind COVID-19 vaccines to help speed the end of the pandemic, a shift that puts the US alongside many in the developing world who want rich countries to do more to get doses to the needy.
Also read: Can you mix-and-match COVID-19 vaccines?
US Trade Representative Katherine Tai announced the government’s position, amid World Trade Organisation talks about a possible temporary waiver of its protections that would allow more manufacturers to produce the life-saving vaccines.
“The Administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for COVID-19 vaccines,” Tai said in a statement.
She cautioned that it would take time to reach the required global “consensus” to waive the protections under WTO rules, and US officials said it would not have an immediate effect on the global supply of COVID-19 shots.
In a tweet, the director of the Africa Centres for Disease Control and Prevention, John N. Nkengasong, said the Africa CDC welcomed the waiver and called the decision “leadership in action.” He added: “History will remember this decision as a great act of humanity!”
Tai’s announcement came hours after WTO Director-General Ngozi Okonjo-Iweala spoke to a closed-door meeting of ambassadors from developing and developed countries that have been wrangling over the issue, but agree on the need for wider access to COVID-19 treatments.
The WTO’s General Council took up the issue of a temporary waiver for intellectual property protections on COVID-19 vaccines and other tools, which South Africa and India first proposed in October. The idea has gained support among some progressive lawmakers in the West.
More than 100 countries have come out in support of the proposal, and a group of 110 members of Congress — all fellow Democrats of Biden — sent him a letter last month that called on him to support the waiver.
Opponents — especially from industry — say a waiver would be no panacea. They insist that production of coronavirus vaccines is complex and can’t be ramped up by easing intellectual property. They also say lifting protections could hurt future innovation.
Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the US decision “will sow confusion between public and private partners, further weaken already strained supply chains and foster the proliferation of counterfeit vaccines.”
Dr. Michelle McMurry-Heath, chief executive of the Biotechnology Innovation Organization trade group, said in a statement that the decision will undermine incentives to develop vaccines and treatments for future pandemics.
“Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine,” she said.
Also read: More support easing vaccine patent rules, but hurdles remain
Pfizer declined to comment on Biden’s announcement, as did Johnson & Johnson, which developed a one-dose vaccine meant to ease vaccination campaigns in poor and rural areas. Moderna and AstraZeneca didn’t immediately respond to requests for comment.
The companies have made some efforts to provide vaccine doses to poor countries at prices well below what they’re charging wealthy nations.
For instance, Johnson & Johnson agreed last week to provide up to 220 million doses of its vaccine to the African Union’s 55 member states, starting in this year’s third quarter, and agreed in December to provide up to 500 million vaccines through 2022 for low-income countries via Gavi, The Vaccine Alliance.
Shares of Pfizer, AstraZeneca and Johnson & Johnson — huge companies with many lucrative products — fell less than 1% on the news. But Moderna, whose vaccine is the company’s only product, fell 6.2% in late-afternoon trading before gaining back two-thirds of a percent in after-hours trading.
It remained unclear how some countries in Europe, which have influential pharmaceutical industries and had previously shared U.S. reservations about the waiver, would respond.
WTO spokesman Keith Rockwell said a panel on intellectual property at the trade body was expected to take up the waiver proposal again at a “tentative” meeting later this month, before a formal meeting June 8-9. That means any final deal could be weeks away at best.
Authors of the proposal have been revising it in hopes of making it more palatable.
Okonjo-Iweala, in remarks posted on the WTO website, said it was “incumbent on us to move quickly to put the revised text on the table, but also to begin and undertake text-based negotiations.”
“I am firmly convinced that once we can sit down with an actual text in front of us, we shall find a pragmatic way forward” that is “acceptable to all sides,” she said.
Co-sponsors of the idea were shuttling between different diplomatic missions to make their case, according to a Geneva trade official who was not authorized to speak publicly on the matter. A deadlock persists, and opposing sides remain far apart, the official said.
The argument, part of a long-running debate about intellectual property protections, centres on lifting patents, copyrights and protections for industrial design and confidential information to help expand the production and deployment of vaccines during supply shortages. The aim is to suspend the rules for several years, just long enough to beat down the pandemic.
The issue has become more pressing with a surge in cases in India, the world’s second-most populous country and a key producer of vaccines — including one for COVID-19 that relies on technology from Oxford University and British-Swedish pharmaceutical maker AstraZeneca.
Michael Yee, a Jefferies Group biotech analyst, wrote to investors that the key access issues for developing countries aren’t patents or price, but an inadequate supply of the materials needed and the know-how to produce the vaccines and keep quality high — which one of Johnson & Johnson’s contract manufacturers in the U.S. failed to do, ruining millions of doses.
“Manufacturing supplies, raw materials, vials, stoppers, and other key materials are in limited supply for 2021,” and may still be next year and beyond, Yee wrote. That’s partly because it takes time to make all those components, and Moderna and Pfizer have commitments to buy them “from major suppliers in huge bulk over the foreseeable future.”
He added that Pfizer previously sought authorization to sell its vaccine to India, which rejected its application and asked that additional studies be run. The U.S., European Union and many other countries have given that emergency authorization.
Proponents, including WHO Director-General Tedros Adhanom Ghebreyesus, note that such waivers are part of the WTO toolbox and insist there’s no better time to use them than during the once-in-a-century pandemic that has taken 3.2 million lives, infected more than 437 million people and devastated economies, according to Johns Hopkins University.
“This is a monumental moment in the fight against COVID-19,” Tedros said in Wednesday statement. He said the U.S. commitment “to support the waiver of IP protections on vaccines is a powerful example of American leadership to address global health challenges.”
Additional reporting by Masudul Hoque and AP.
3 years ago
EU agency: Rare clots possibly linked to AstraZeneca shot
The European Union’s drug regulator will announce the conclusions of its investigation into the possible connection between AstraZeneca’s coronavirus vaccine and rare blood clots later Wednesday, including recommendations that could have far-reaching effects on the use of the shot that is key to global efforts to end the pandemic.
Earlier this week, a senior official from the European Medicines Agency said there was a causal link between the AstraZeneca vaccine and the rare clots that have been seen in dozens of people worldwide, among the tens of millions who have received at least one dose of the shot.
Also Read: Canada pauses AstraZeneca vaccine for under 55
Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, said in comments to Rome’s Il Messaggero newspaper on Tuesday that “it is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets.”
But Cavaleri acknowledged the agency hadn’t yet figured out how exactly the vaccine might be causing these rare side effects. The agency said its evaluation “has not yet reached a conclusion and the review is currently ongoing.”
The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It is also evaluating reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding.
Also Read: UK regulator says AstraZeneca jab safe after 7 clot deaths
The EMA, the World Health Organization and numerous other health authorities have said repeatedly that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risks of rare blood clots.
As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected. To date, most of the cases have been reported in younger women, who are more susceptible to developing such rare clots anyway, making understanding what is causing the clots potentially more difficult.
“The problem is these clots are very unusual, and we don’t really know what the background rate of them is, so it’s very hard to know if the vaccine is contributing to this,” said Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee.
A full investigation would likely take months, but English said given the urgency of the continuing pandemic, regulators would likely make a quick decision.
Also Read: What we know about AstraZeneca blood clot reports
“It’s very likely we will see a suspension of the vaccine’s use in certain groups while they do the further investigations to give us clearer answers,” English said.
In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the potentially life-saving vaccine.
The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine’s effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca’s credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.
English said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences.
“We can’t afford not to use this vaccine if we are going to end the pandemic,” he said.
That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunization campaign and a pillar of the U.N.-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries. It has been endorsed for use in more than 50 countries, including by the 27-nation EU and WHO. U.S. authorities are still evaluating the vaccine.
The governor of Italy’s northern Veneto region said any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot.
“If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters on Wednesday.
The latest suspension of AstraZeneca came in Spain’s Castilla y León region, where health chief Verónica Casado said Wednesday that “the principle of prudence” drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary.
“If there are in fact individuals of a certain age group that could have a higher risk (of clotting) then we need to adjust its use,” Casado told Spanish public radio. “We are not questioning AstraZeneca. We need all the vaccines possible to reach the goal of 70% of the adult population.”
French health authorities said they, too, were awaiting EMA’s conclusions and would follow the agency’s recommendations, especially for the 500,000 people who have received a first dose of AstraZeneca.
Even officials in Asia said they were keen to hear the EMA’s decision. On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca’s vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.
The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review.
English, the former chair of the British drug regulator, said that even rare, serious side effects are seen with established vaccines and that policymakers often decide that bigger public health goals warrants their use, citing the polio vaccine as an example. For every million doses that are given of the oral polio vaccine, about one child is paralyzed from the live virus contained in the vaccine.
On Tuesday, AstraZeneca and Oxford University, which developed the vaccine, paused a study of the shot in children while the U.K. regulator evaluates the link between the shot and rare blood clots in adults.
3 years ago
UK regulator says AstraZeneca jab safe after 7 clot deaths
Britain’s medicines regulator is urging people to continue taking the AstraZeneca coronavirus vaccine, despite revealing that seven people in the U.K. have died from rare blood clots after getting the jab.
The Medicines and Healthcare Regulatory Agency, or MHRA, said it wasn't clear if the shots are causing the clots, and that its “rigorous review into the U.K. reports of rare and specific types of blood clots is ongoing.”
Also Read: Dutch temporarily halt AstraZeneca shots for under-60s
Though the agency said late Friday that seven people had died as a result of developing blood clots, it didn’t disclose any information about their ages or health conditions.
In total, MHRA said had identified 30 cases of rare blood clot events out of 18.1 million AstraZeneca doses administered up to and including March 24. The risk associated with this type of blood clot is “very small,” it added.
Also Read:What we know about AstraZeneca blood clot reports
“The benefits of COVID-19 vaccine AstraZeneca in preventing COVID-19 infection and its complications continue to outweigh any risks and the public should continue to get their vaccine when invited to do so,” said Dr. June Raine, the agency’s chief executive.
Concerns over the AstraZeneca vaccine has already prompted some countries including Canada, France, Germany and the Netherlands to restrict its use to older people. The U.K., which has rolled out coronavirus vaccines faster than other European nations, is particularly reliant on the AstraZeneca vaccine, which was developed by scientists at the University of Oxford.
MHRA's view about the relative benefits of the vaccine is shared by the European Medicines Agency. It has said a causal link between unusual blood clots in people who have had the vaccine is “not proven, but is possible," and that the benefits of the vaccine outweigh the risks of side effects. The World Health Organization has also urged countries to continue using the jab.
Also Read: Africa CDC says India vaccine woes could be 'catastrophic'
Adam Finn, a professor of pediatrics at the University of Bristol, said the “extreme rarity” of the blood-clotting events in the context of the millions of jabs administered in the U.K. makes the decision facing people very straightforward.
“Receiving the vaccine is by far the safest choice in terms of minimizing individual risk of serious illness or death,” he said.
A more detailed look at the MHRA’s findings show that of the 30 cases, 22 related to cerebral venous sinus thrombosis, which stops blood draining from the brain properly, and eight were connected with other thrombosis events with low platelets.
It said there were no reports of any blood-clotting events around the Pfizer/BioNTech vaccine, which has also been widely rolled out in the U.K.
3 years ago
AstraZeneca confirms strong vaccine protection after US rift
AstraZeneca insisted Wednesday that its COVID-19 vaccine is strongly effective even after counting additional illnesses in its disputed U.S. study, the latest in an extraordinary public rift with American officials.
In a late-night press release, AstraZeneca said it had recalculated data from that study and concluded the vaccine is 76% effective in preventing symptomatic COVID-19, instead of the 79% it had claimed earlier in the week.
Just a day earlier, an independent panel that oversees the study had accused AstraZeneca of cherry-picking data to tout the protection offered by its vaccine. The panel, in a harsh letter to the company and to U.S. health leaders, said the company had left out some COVID-19 cases that occurred in the study, a move that could erode trust in the science.
Also Read: AstraZeneca: US data shows vaccine effective for all adult
Data disputes during ongoing studies usually remain confidential but in an unusual step, the National Institutes of Health publicly called on AstraZeneca to fix the discrepancy.AstraZeneca had been counting on findings from a predominantly U.S. study of 32,000 people to help rebuild confidence in a vaccine that, despite being widely used in Britain, Europe and other countries, has had a troubled rollout. Previous studies have turned up inconsistent data about its effectiveness, and then last week a scare about blood clots had some countries temporarily pausing inoculations.
Now the question is whether the company’s newest calculations end the tension.
Also Read: US: AstraZeneca may have used outdated info in vaccine trial
Earlier Wednesday, Dr. Anthony Fauci, the top U.S. infectious disease expert, told reporters he hoped that when all the data was publicly vetted by federal regulators, it would dispel any hesitancy caused by the spat. He predicted it would “turn out to be a good vaccine.”
AstraZeneca’s newest calculations were based on 190 COVID-19 cases that occurred during the study, 49 more than it had included earlier in the week. The vaccine appears especially protective against the worst outcomes, with no severe illnesses or hospitalizations among vaccinated study volunteers compared to eight severe cases among those given dummy shots, the company said. It didn’t provide a breakdown of the rest of the cases.
European authorities had questioned how protective the vaccine is in older adults. In the U.S. study, it was 85% effective in volunteers 65 and older, the company said. The study didn’t turn up safety concerns.
The updated information “confirms that our COVID-19 vaccine is highly effective in adults, including those aged 65 years and over,” AstraZeneca research chief Mene Pangalos said in a statement. He said the company looks forward to “the rollout of millions of doses across America.”
The study hasn’t ended so additional COVID-19 cases can accrue. AstraZeneca cautioned that 14 additional possible cases already are being examined, which could lead to further changes in the data.
The company intends to seek Food and Drug Administration clearance of the vaccine within a few weeks. The FDA will publicly debate all the evidence with its outside advisers before making a decision.
3 years ago
Study finds 'Oxford vaccine' may reduce virus transmission
AstraZeneca’s COVID-19 vaccine does more than prevent people from falling seriously ill — it appears to reduce transmission of the virus and offers strong protection for three months on just a single dose, researchers said Wednesday in an encouraging turn in the campaign to suppress the outbreak.
3 years ago
‘Thank you’: Hasina to Modi
Prime Minister Sheikh Hasina on Thursday thanked her Indian counterpart Narendra Modi for sending the Oxford vaccine produced in India as a gift for Bangladesh.
3 years ago
Vaccine gift a sign of Hasina-Modi strong ties: FM
Foreign Minister Dr AK Abdul Momen on Thursday said the arrival of 20 lakh doses of Oxford vaccine from India shows the sign of strong relations and goodwill between Prime Minister Sheikh Hasina and her Indian counterpart NarendraModi.
3 years ago
EU regulator is considering Oxford-AstraZeneca vaccine
The European Medicines Agency said Tuesday that AstraZeneca and Oxford University have submitted an application for their COVID-19 vaccine to be licensed across the European Union.
3 years ago
Covid-19: Bangladesh allows emergency use of Oxford-AstraZeneca vaccine
The government on Thursday approved the emergency use of the Oxford-AstraZeneca Covid-19 vaccine.
3 years ago
Vaccination campaign picks up speed around the world
The campaign to vanquish the coronavirus is picking up speed, with Britain beginning to dispense the second vaccine in its arsenal Monday. But authorities in France and elsewhere in Europe are coming under fire for slow rollouts and delays.
3 years ago